Application for new drug of risperidone microsphere injection (ly03004) of LVYE pharmaceutical in the United States

Green leaf Pharmaceutical Group recently announced that the US Food and Drug Administration (FDA) confirmed that the risperidone microsphere injection (ly03004) developed by the company does not need any more clinical trials, and can submit a new drug application (NDA) in the US This indicates that LVYE pharmaceutical, the first microsphere preparation product independently developed by China, will enter the US market in the near future After ly 03004 goes on the market, it is expected to improve the medication compliance of oral antipsychotics in schizophrenics, and simplify the treatment course of schizophrenia, because it only needs to be injected once every two weeks In addition, compared with another marketed product, ly 03004 does not need to take oral preparation three weeks after the first injection, and can reach steady-state blood concentration faster Ly 03004 is a kind of sustained-release microsphere preparation, which is used in the treatment of schizophrenia and / or schizoaffective disorder by intramuscular injection At the meeting of green leaf pharmaceutical and FDA in September, FDA confirmed that the critical clinical trials completed earlier this year involving 108 patients in the United States were sufficient to support ly03004 to submit NDA in the United States through 505 (b) (2), without any further clinical trials At present, LVYE pharmaceutical has started to prepare the NDA report of ly 03004 Schizophrenia is a serious mental disease, which has the characteristics of interrupting thinking, influencing language, concept and self cognition According to the World Health Organization, more than 21 million people around the world are suffering from schizophrenia, and one in every two schizophrenics has not been treated According to the National Institutes of health, an estimated 2.4 million Americans suffer from schizophrenia LVYE pharmaceutical believes that ly 03004 has good market potential and will enrich its product portfolio In addition to the United States and other countries, LVYE pharmaceutical will also work for European and Japanese regulatory authorities to obtain the listing approval of ly 03004 In addition to ly 03004, green leaf pharmaceutical is currently developing a variety of new drugs in the United States, Europe and Japan The following is the analysis of e-drug managers: first, as the first Chinese new drug to enter the new drug application (NDA) process in the United States, how good is it? In brief, the application of new drugs in the United States can be divided into two stages: clinical trial application of new drugs (ind) and new drug listing application (NDA) IND is generally referred to as phase I, II and III clinical trials To complete this phase in the United States is also a huge cost, time-consuming and highest threshold obstacle for Chinese pharmaceutical enterprises Green leaf is the first case for many Chinese pharmaceutical companies that are committed to internationalization For example, recently, the PD-1 McAb variety that Hengrui sold to Incyte in the United States for up to $800 million must complete this stage if it wants to enter the U.S market, and the completion time is at least five years later; the clinical progress of its highly concerned variety pyrrolidine in the United States is still in phase I clinical stage In the NDA stage, a review team is usually set up by different professionals such as pharmacology, chemistry, medicine, statistics, drug dynamics, bacteriology, etc the key step is for FDA to convene an advisory committee to discuss the experimental results and positive and negative opinions in detail How long will it take? Industry insiders told Facebook that the fastest NDA audit record in the history of the pharmaceutical industry is 4 working days! In theory, LVYE's ly03004 may be approved at any time In fact, although most of the applications for new drug marketing license have too much information, they can often be reviewed within the regular time, but there may be special circumstances Therefore, the green leaf is cautious about the time when the new drug will be put on the market According to US law, the whole NDA audit process needs to be completed within 10 months at the slowest Secondly, why does "risperidone microsphere injection (ly03004) need no further clinical trial"? This has to start with green leaf's approval of the new drug development It is understood that at the meeting of green leaf pharmaceutical and FDA in September, FDA confirmed that the key clinical trials completed earlier this year, involving 108 patients in the United States, were sufficient to support ly03004 to submit NDA in the United States through 505 (b) (2), without any further clinical trials At present, LVYE pharmaceutical has begun to prepare the NDA report of ly03004 505 (b) (2) means that its innovative path is to change the dosage form, the way of administration, the new indications, etc Ly03004 is a kind of sustained-release microsphere preparation, which is used in the treatment of schizophrenia or schizoaffective disorder by intramuscular injection In other words, the biggest technical gold content of this new drug innovation lies in the obvious advantages of risperidone for the current market drug The sustained-release microsphere function is slow-release and long-term, that is to say, it can release the drug stably in a long time, and the drug interval is short, so it has advantages over the old dosage form Li Youxin, senior vice president of LVYE Pharmaceutical Group, said: "after ly03004 goes on the market, it is expected to improve the medication compliance of oral antipsychotics in schizophrenics and simplify the treatment of schizophrenia, because it only needs to be injected once every two weeks In addition, compared with another product already on the market, LY03004 does not need to take oral preparation three weeks after the first injection, and can reach the stable blood concentration more quickly " In 2013, the global market size of this drug was about 1.3 billion US dollars Third, will the fast track built by green leaves have a chance of failure? Different from the new drug application channels in other countries, there is still a possibility that the new drug application will be killed when FDA passes the clinical trial stage, but industry insiders predict that "the possibility that ly03004 of green leaf will be killed is very low." The reason also lies in the 505 (b) (2) approach Unlike 505 (b) (1) completely innovative new drugs, the latter requires a large number of clinical trial data to support and convince FDA about the effectiveness and safety of new drugs, while 505 (b) (2) stands on the shoulders of predecessors, the most important thing to prove is the defect filling of self-made drugs compared with the current market, as well as the hard PK advantage of clinical data In addition, green leaf pharmaceutical said: believe ly03004 has good market potential and will enrich the company's product portfolio In addition to the United States and other countries, LVYE pharmaceutical will also work to obtain the listing approval of ly03004 from European and Japanese regulatory authorities In addition to ly03004, green leaf pharmaceutical is currently developing a variety of new drugs in the United States, Europe and Japan.